[Ip-health] Rep. Waxman Comments on the 5th Anniversary of the May 10th Agreement

Krista Cox krista.cox at keionline.org
Mon May 14 19:58:28 PDT 2012

Briefing on the 5th Anniversary of the May 10 Agreement

Remarks of Rep. Henry A. Waxman
as prepared for delivery

May 10, 2012

I thank my colleagues on the Ways and Means Committee for organizing this

Five years ago today, we achieved a breakthrough, taking a critical step
toward a more progressive trade policy that raises standards for labor, the
environment, and public health.

I became involved because much of the U.S. proposal on trade and medicines
was being taken from Hatch-Waxman, the landmark law that delivered generic
drug competition to the American marketplace.  The only problem was that
our trade proposals were being designed to have the exact opposite effect -
delaying generic competition in poor countries, countries in which the vast
majority of people could not afford brand name medicines.

Hatch-Waxman also offered incentives to innovators to encourage them to
reinvest in developing new drugs.  But it was a careful balance, addressing
market dynamics that simply do not exist in developing countries.

>From a public health perspective, I was also concerned that policies in the
Central America Free Trade Agreement and other U.S. FTAs were undermining
the WTO’s 2001 Doha Declaration on TRIPS and Public Health.  The Doha
Declaration reaffirmed that trade rules for intellectual property can and
should be interpreted and implemented in ways that protect public health
and promote access to medicines for all.

And so, on May 10, 2007, I joined my colleagues in seeking changes in how
intellectual property rules would apply to medicines.

These changes revolved around two key principles:

One, that U.S. trade policy needs to take into account the needs of
developing countries, where the availability of affordable medicine can
mean the difference between life and death.

And, two, that poor patients in poor countries should not have to wait
longer than we do in the United States for access to generic medicines.

For example, under the May 10 agreement, new drugs would still get 5 years
of exclusive marketing rights. But there was a safeguard available so that
a generic medicine could be approved in a developing country no later than
in the United States.

The May 10 agreement also offered safeguards to prevent drug regulatory
authorities from being forced to act as patent police and to mitigate the
risk that patent abuses could keep affordable generic medicines from the

And, language was added to make clear that the amended Free Trade
Agreements do not and should not prevent countries from taking measures to
protect public health.

Many advocates for public health and developing countries wanted us to go
further.  However, the compromise emerged from the confines of signed
agreements and negotiations with a Republican Administration.  And just as
with the labor and environment provisions in the May 10 agreement, we
considered it to be a model we could continue to improve upon.

Unfortunately, 5 years later, as the U.S. engages in the Trans Pacific
Partnership talks, we have once again lost ground.  The USTR’s intellectual
property proposal outlined for the TPP talks features neither the
principles nor the safeguards we advanced on May 10, 2007.

Instead, we are back to a one-size-fits-all paradigm.

Once again, the U.S. proposal would leave smaller and poorer developing
country patients waiting longer than patients in the United States for
access to a generic drug.

To be clear, the TPP negotiations include developing countries, like
Vietnam, a country in the U.S. PEPFAR AIDS relief program with 280,000
people living with HIV.  It includes Peru, a country where nearly one in
three people live in poverty and the existing US-Peru FTA already has the
May 10 changes.

These are small poverty stricken nations, where the brand industry can make
only marginal profits, but the impact of such agreements on a large
population of poor patients could be severe.

We need to do better.  If the Administration is serious about striking a
balance, it needs to go back to the drawing board and come up with a
reasonable mix of incentives for innovators that do not pose unnecessary
barriers to poor patients seeking access to low cost generic medicines.

On this 5 year anniversary we should reflect on why the May 10 agreement
was necessary and why it should continue to be a premise for our trade
agreements moving forward.

Krista L. Cox
Staff Attorney
Knowledge Ecology International
(202) 332-2670

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